Indication
- Therapeutic and prophylactic treatment of candidiasis of the oropharyngeal cavity and the gastrointestinal tract.
- Oral and intestinal fungal infections.
Composition
Each 1g of Dactonaz® Oral Gel contains:
- Miconazole 20 mg
Dosage
Oropharyngeal candidiasis:
- Infants (6–24 months):
- 1.25 ml four times a day.
- Children (2–6 years):
- 2.5 ml four times a day.
- Children (above 6 years):
- 5 ml four times a day.
- Adults:
- 5 ml to 10 ml four times a day.
* The gel should be applied to the affected area(s).
* The gel should be kept in the mouth as long as possible before being swallowed .
* The treatment should be continued for at least a week after the symptoms have disappeared.
Gastrointestinal tract candidiasis:
- Infants, Children and Adults:
- 20 mg per kg body weight per day, administrated in four divided doses.
* The treatment should be continued for at least a week after the symptoms have disappeared.
- The active component of Dactonaz® Oral Gel is miconazole that is an imidazole antifungal agent with antimicrobial activity against some Gram-Positive bacteria including staphylococci and streptococci.
- Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the cell membrane, resulting in leakage of the essential intracellular constituents, and finally lead to fungal cell necrosis.
- Dactonaz® Oral Gel is poorly absorbed from gastro-intestinal tract with little systemic side effects.
Each 1g of Dactonaz® Oral Gel contains:
- Miconazole 20 mg
- Therapeutic and prophylactic treatment of candidiasis of the oropharyngeal cavity and the gastrointestinal tract.
- Oral and intestinal fungal infections.
- Hypersensitivity to Miconazole.
- In infants less than 6 months of age or in those whose swallowing reflex is not yet sufficiently developed .
- In patients with liver dysfunction .
- Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems, This can result in an increase and/or prolongation of their effects, including adverse effects, therefore oral miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 :
- Substrates known to prolong the QT-interval e.g. : (astimazole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine).
- Ergot alkaloids, Triazolam and oral midazolam.
- HMG-CoA reductase inhibitors such as simvastatin and lovastatin.
- HIV protease inhibitors such as saquinavir.
- Certain antineoplastic agents such as (vinca alkaloids,busulfan and docetaxel) .
- Certain calcium channel blockers such as (dihydropyri dines and verapamil) .
- Certain immunosuppressive agents: (cyclosporine, tacrolimus, sirolimus {rapamycin} ).
- Use during pregnancy: It should only be used during the first trimester of pregnancy when considered essential to the welfare of the patient.
- Use during lactation: It is not known whether miconazole is excreted in breast milk .However,problems in humans have not been documented, caution should be exercised.
- Mild Gastro-intestinal disturbances(nausea, vomiting and diarrhoea) usually on long-term treatment, and in very rare cases allergic reactions may be observed .
- In very rare cases hepatitis .
Oropharyngeal candidiasis:
- Infants (6–24 months):
- 1.25 ml four times a day.
- Children (2–6 years):
- 2.5 ml four times a day.
- Children (above 6 years):
- 5 ml four times a day.
- Adults:
- 5 ml to 10 ml four times a day.
* The gel should be applied to the affected area(s).
* The gel should be kept in the mouth as long as possible before being swallowed .
* The treatment should be continued for at least a week after the symptoms have disappeared.
Gastrointestinal tract candidiasis:
- Infants, Children and Adults:
- 20 mg per kg body weight per day, administrated in four divided doses.
* The treatment should be continued for at least a week after the symptoms have disappeared.
Caution should be exercised and advisable to monitor Dactonaz® Oral Gel and the following drugs levels(If these two drugs are used concomitantly, because their activity can be potentiated):-
- Oral anticoagulants such as warfarin.
- Phenytoin.
- Certain hypoglycemics such as sulfonylurea group.
- Tube of 20g Oral Gel. .
- Store at a temperature below 25°C .